FLUIDASA 20 mg/ml ORAL DROPS IN SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FLUIDASA 20 mg/ml oral drops in solution

Mepifilina (mepiramine acefilinate)

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What Fluidasa Drops is and what it is used for
2. Before taking Fluidasa Drops
3. How to take Fluidasa Drops
4. Possible side effects
5. Storing Fluidasa Drops
6. Further information

1. What FLUIDASA DROPS is and what it is used for

This medicine contains mepifilina, which belongs to the group of antihistamine medicines.

Fluidasa Drops is used for the treatment of bronchoconstriction in patients with acute and chronic bronchitis (inflammation of the bronchi).

2. Before taking FLUIDASA DROPS

Do not take Fluidasa Drops:

• If you are allergic (hypersensitive) to mepifilina or any of the other ingredients of Fluidasa Drops.
• If you have liver disease.
• If you have urinary bladder obstruction.
• If you have symptomatic prostatic hypertrophy or urinary retention.
• If you have narrow-angle glaucoma.

Be cautious when taking Fluidasa Drops:

• If you are sensitive to antihistamines (allergy medicines), as patients sensitive to one antihistamine may be sensitive to others.
• If you are elderly, as you are more likely to experience side effects such as dizziness, sedation, confusion, low blood pressure, dry mouth, or urinary retention. If these effects persist or are severe, you should inform your doctor, as the medication may need to be discontinued.
• It is not recommended for use in newborns or premature infants, as this age group is more sensitive to some effects of the medicine, such as anticholinergic effects (e.g., central nervous system stimulation) and a greater tendency to convulsions.

Using other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Especially, inform your doctor if you are taking the following medicines, as some effects may be increased:

• Medicines from the anticholinergic group (e.g., some medicines used for relief of stomach, intestine, or bladder spasms or contractions)
• Medicines used for the treatment of depression, such as monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, or maprotiline.
• If skin allergy tests need to be performed, it is recommended to discontinue the administration of Fluidasa Drops at least 72 hours before starting the test, as it may give false-negative results (negative results that are actually positive).

Taking Fluidasa Drops with food and drinks

You should avoid consuming alcoholic beverages during the administration of this medicine, as it may increase the effects of alcohol.

Pregnancy and breastfeeding

It is not recommended to take Fluidasa Drops during pregnancy.

It is not recommended to take Fluidasa Drops during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

Fluidasa Drops may cause drowsiness, so you should avoid driving or operating hazardous machinery if affected.

Important information about some of the ingredients of Fluidasa Drops

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

3. How to take FLUIDASA DROPS

Fluidasa Drops is administered orally.

Follow the administration instructions of Fluidasa Drops exactly as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

1 drop contains approximately 1 mg of mepifilina.

Infants:The average dose is 3 mg per kg of body weight and day, divided into 4 doses. Generally, as a guideline and in relation to weight, it is equivalent to 3 to 6 drops every 6 hours. The maximum recommended dose is 6 mg per kg of body weight and day, divided into 4 doses.

As a guideline, the following doses can be followed in infants:

Children: The average dose is 8 mg per kg of body weight and day, divided into 4 doses. Generally, as a guideline and in relation to weight, it is equivalent to 15 to 30 drops every 6 hours.

The maximum dose is 18 mg per kg of body weight and day, divided into 4 doses.

If you think that the effect of Fluidasa Drops is too strong or too weak, consult your doctor or pharmacist.

As a guideline, the following doses can be followed in children:

If you take more Fluidasa Drops than you should:

If you have taken more Fluidasa Drops than you should, consult your doctor or pharmacist immediately.

In cases of overdose, symptoms of anticholinergic effects such as clumsiness, instability, intense drowsiness, dry mouth, nose, or throat, flushing or redness, variations in the normal heartbeat, central nervous system depression (hallucinations), or low blood pressure may appear. In children, anticholinergic stimulant effects on the central nervous system are more likely.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone: 91 562 04 20.

If you forget to take Fluidasa Drops:

Do not take a double dose to make up for forgotten doses.

Take your dose as soon as possible and continue taking it every day at the time indicated by your doctor.

4. Possible side effects

Like all medicines, Fluidasa Drops can cause side effects, although not everybody gets them.

The side effects found have been:

Very common (at least 1 in 10 patients): drowsiness.

Common (at least 1 in 100 patients): blurred vision, confusion, difficulty urinating, dizziness, dry mouth, rapid heartbeat, ringing in the ears, skin rash, discomfort or stomach pain.

Uncommon (at least 1 in 1000 patients): abnormal blood conditions (dysscrasias) and variations in the normal heartbeat.

If you think that any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing FLUIDASA DROPS

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Fluidasa Drops after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Further information

Composition of Fluidasa Drops

• The active ingredient is: mepifilina (mepiramine acefilinate). Each drop contains approximately 1 mg of mepifilina. 20 drops are equivalent to 1 ml.
• The other ingredients are: sodium saccharin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), vanilla flavor, and purified water.

Appearance of the product and packaging content

Topaz bottle containing 30 ml of oral solution and a dropper cap.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Teofarma, S.r.l.

Via F. Lli Cervi, 8 – 27010 Valle Salimbene (PV) - Italy.

Manufacturer:

Teofarma, S.r.l.

Viale Certosa. 8/A - I-27100 Pavia – Italy

Other presentations

Fluidasa Solution. Bottle of 250 ml oral solution

Fluidasa Capsules. Package of 20 capsules.

Fluidasa Injectable. Package containing 10 ampoules of 5 ml.

This leaflet was approved in July 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/